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NCT02012231 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers.
A Phase 1 study, sponsored by Fore Biotherapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02012231: Clinical Trial Phase 1 study, sponsored by Fore Biotherapeutics.
NCT02012231 is a Phase 1 study that was terminated before completion, run by Fore Biotherapeutics. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02012231, a Phase 1 study, was terminated before completion, sponsored by Fore Biotherapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension Cohorts (Phase IIa portion). The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with advanced BRAF-mutated cancers.
Primary Outcome
Physical examinations, vital signs, 12-lead electrocardiograms, adverse events, hematology, serum chemistry, and urinalysis will be used to assess safety and tolerability.
Interventions
- DRUG PLX8394
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Why NCT02012231 stopped before completion
NCT02012231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which PLX8394 is the first listed.
NCT02012231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02012231 about?
NCT02012231 is a clinical study titled "Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers.". The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension Cohorts (Phase IIa portio...
What is the current status of trial NCT02012231?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2014-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02012231?
The interventions under investigation include: PLX8394 (DRUG).
Who is sponsoring clinical trial NCT02012231?
This trial is sponsored by Fore Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02012231's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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